HiTech Health holds the following authorisations, granted by the Health Product Regulatory Authority (HPRA), to support the importation and/or release of your products into the EU market in a controlled and regulated manner:
  • Manufacturer’s/Importer’s Authorisation (MIA) for Commercial Products

  • Manufacturer’s/Importer’s Authorisation (MIA) for Clinical Trial Products

Import and release medicines into EU market

Manufacturer’s/Importer’s Authorisation for Commercial Products

A Manufacturer’s / Importer’s Authorisation (MIA) is required in the EU for importing, re-packaging, re-labelling and releasing to market batches of human medicinal products.

HiTech Health provides clients the opportunity to avail of our commercial MIA to certify medicinal products for release to the EU market or for export to other markets, instead of having to substantially invest in the costly and thorough process of obtaining their own MIA licence. By partnering with HiTech Health, companies would benefit from the three main advantages below:

  1. Experienced cross-functional team: To support clients every step of the way. HiTech Health employees have extensive experience in Quality, Operations and Supply Chain and have a proven track-record of delivering efficient results for clients.
  2. Financial savings: Instead of setting up an office and hiring employees in the EU, HiTech Health clients can avail of cost-effective strategies by contracting HiTech Health to provide the required quality services with no obligations for long-term commitments.
  3. Timeline reduction: Developing a Quality Management System (QMS) and undertaking a MIA application process could take up to 12 months. We can catalyse this lead-time to 3-4 months, accelerating access to patients.  Following Brexit, Ireland is the only country in the EU with English as a first language.

Manufacturer’s/Importer’s Authorisation for Clinical Trial Products

HiTech Health is authorised to import and certify Investigational Medicinal Products (IMPs) for use in clinical trials within the EU on behalf of clients, allowing them to focus on their other core business activities. We can support the release and supply of IMPs to clinical trial sponsor sites throughout the EU in a cost-effective and timely manner.

Our experienced in-house team have extensive knowledge of clinical trial sponsors and centres across Europe and can assist with supporting products from development to commercialisation.

Get in touch with us

Our team would be delighted to hear from you.
Why not call us today to discuss how we can help.

Let’s Talk

5/7 Main Street
Blackrock
Co.Dublin
Ireland
info@hitech-health.com
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835